{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "192681", "product_res_number": "Z-1076-2022", "event_date_initiated": "2022-03-03", "event_date_posted": "2022-05-18", "recall_status": "Open, Classified", "res_event_number": "89852", "product_code": "JCT", "product_description": "Atrium Advanta V12 Covered Stent System (OUS only).\n\nProduct Code/Part Number:\n85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360 85361 85364 85365 85388 85389 85390 85391 85392 85394 85395 85396 85397 85398 85370 85371 85372 and 85379.\n\nProduct Code/UDI /Description:\n85320\t650862853209\tAdvanta V12 Covered Stent, 5mm x 38mm x 80cm;\n85321\t650862853216\tAdvanta V12 Covered Stent, 5mm x 59mm x 80cm;\n85322\t650862853223\tAdvanta V12 Covered Stent, 6mm x 38mm x 80cm;\n85323\t650862853230\tAdvanta V12 Covered Stent, 6mm x 59mm x 80cm\n85324\t650862853247\tAdvanta V12 Covered Stent, 7mm x 38mm x 80cm;\n85325\t650862853254\tAdvanta V12 Covered Stent, 7mm x 59mm x 80cm;\n85326\t650862853261\tAdvanta V12 Covered Stent, 8mm x 38mm x 80cm;\n85327\t650862853278\tAdvanta V12 Covered Stent, 8mm x 59mm x 80cm;\n85328\t650862853285\tAdvanta V12 Covered Stent, 9mm x 38mm x 80cm;\n85329\t650862853292\tAdvanta V12 Covered Stent, 9mm x 59mm x 80cm;\n85330\t650862853308\tAdvanta V12 Covered Stent, 5mm x 38mm x120cm;\n85331\t650862853315\tAdvanta V12 Covered Stent, 5mm x 59mm x120cm;\n85332\t650862853322\tAdvanta V12 Covered Stent, 6mm x 38mm x120cm;\n85333\t650862853339\tAdvanta V12 Covered Stent, 6mm x 59mm x120cm;\n85334\t650862853346\tAdvanta V12 Covered Stent, 7mm x 38mm x120cm;\n85335\t650862853353\tAdvanta V12 Covered Stent, 7mm x 59mm x120cm;\n85336\t650862853360\tAdvanta V12 Covered Stent, 8mm x 38mm x120cm;\n85337\t650862853377\tAdvanta V12 Covered Stent, 8mm x 59mm x120cm;\n85338\t650862853384\tAdvanta V12 Covered Stent, 9mm x 38mm x120cm;\n85339\t650862853391\tAdvanta V12 Covered Stent, 9mm x 59mm x120cm;\n85340\t650862853407\tAdvanta V12 Covered Stent, 5mm x 16mm x 80cm;\n85341\t650862853414\tAdvanta V12 Covered Stent, 5mm x 22mm x 80cm;\n85342\t650862853421\tAdvanta V12 Covered Stent, 6mm x 16mm x 80cm;\n85343\t650862853438\tAdvanta V12 Covered Stent, 6mm x 22mm x 80cm;\n85344\t650862853445\tAdvanta V12 Covered Stent, 7mm x 16mm x 80cm;\n85345\t650862853452\tAdvanta V12 Covered Stent, 7mm x 22mm x 80cm;\n85350\t650862853506\tAdvanta V12 Covered Stent, 5mm x 16mm x 120cm;\n85351\t650862853513\tAdvanta V12 Covered Stent, 5mm x 22mm x 120cm;\n85352\t650862853520\tAdvanta V12 Covered Stent, 6mm x 16mm x 120cm;\n85353\t650862853537\tAdvanta V12 Covered Stent, 6mm x 22mm x 120cm;\n85354\t650862853544\tAdvanta V12 Covered Stent, 7mm x 16mm x 120cm;\n85355\t650862853551\tAdvanta V12 Covered Stent, 7mm x 22mm x 120cm;\n85360\t650862853605\tAdvanta V12 Covered Stent, 10mm x 38mm x 80cm;\n85361\t650862853612\tAdvanta V12 Covered Stent, 10mm x 59mm x 80cm;\n85364\t650862853643\tAdvanta V12 Covered Stent, 10mm x 38mm x 120cm;\n85365\t650862853650\tAdvanta V12 Covered Stent, 10mm x 59mm x 120cm;\n85370\t650862853704\tAdvanta V12 Large Diameter, 12mm x 29mm x 80cm;\n85371\t650862853711\tAdvanta V12 Large Diameter, 12mm x 41mm x 80cm;\n85372\t650862853728\tAdvanta V12 Large Diameter, 12mm x 61mm x 80cm;\n85379\t650862853797\tAdvanta V12 Large Diameter, 12mm x 29mm x 120cm;\n85388\t650862853889\tAdvanta V12 Covered Stent, 5mm x 32mm x 80cm;\n;85390\t650862853902\tAdvanta V12 Covered Stent, 7mm x 32mm x 80cm;\n85391\t650862853919\tAdvanta V12 Covered Stent, 8mm x 32mm x 80cm;\n85392\t650862853926\tAdvanta V12 Covered Stent, 9mm x 32mm x 80cm;\n85394\t650862853940\tAdvanta V12 Covered Stent, 5mm x 32mm x 120cm;\n85395\t650862853957\tAdvanta V12 Covered Stent, 6mm x 32mm x 120cm.\n85396\t650862853964\tAdvanta V12 Covered Stent, 7mm x 32mm x 120cm\n85397\t650862853971\tAdvanta V12 Covered Stent, 8mm x 32mm x 120cm\n85398\t650862853988\tAdvanta V12 Covered Stent, 9mm x 32mm x 120cm", "code_info": "All lots", "firm_fei_number": "3011175548", "recalling_firm": "Atrium Medical Corporation", "address_1": "40 Continental Blvd", "city": "Merrimack", "state": "NH", "postal_code": "03054-4332", "additional_info_contact": "SAME\n603-880-1433", "reason_for_recall": "Firm has observed increased rate of customer complaints related to separation of the balloon or catheter hub from the delivery catheter during delivery system withdrawal causing procedural delay and possible administration of additional anesthesia and contrast which may impact patients' renal function. Potential harms include occlusion or embolism and associated response, with specific outcomes such as amputation, embolism, loss of organ function, organ infarction, or tissue infarction.\n\n***Updated June 2023*** Additional surgical stress caused by prolonged interventional surgery has the potential to lead to myocardial infarction or death.", "root_cause_description": "Device Design", "action": "Atrium/Getinge issued Urgent Field Safety Notification to Hospitals (OUS) via on 3/03/22 via email. Letter states reason for recall, health risk and action to take:\nThe company is updating the Advanta V12 Covered Stent System Instructions for Use (IFU). \n\nREVISED: Deflation and Withdrawal Instructions:\nDeflate balloon by pulling vacuum on the inflation device to its maximum volume and allow sufficient time for full deflation. IMPORTANT: Visually verify full deflation of the balloon via fluoroscopy before attempting to withdraw the delivery system.\n\nYou may continue to use the Advanta V12 Covered Stent Systems, with the consideration of this revised information, which is included on the following page.\n\nNo Devices Need to Be Returned.\n\nIf you have any questions, please contact your local Getinge representative.\n\n***UPDATE APRIL 2022***\nOn April 22, 2022, the firm expanded its recall to include the iCast Covered Stent System. If the device is inflated/deflated using higher concentrations of contrast media or other viscous fluid, as may occur in off-label endovascular procedures, a balloon may take longer to deflate than prescribed in the iCast IFU. \n\nLetters were issued to consignees via FedEx with delivery receipt. Customers were informed they may continue to use the iCast covered stent with the consideration of the Deflation and Withdrawal Instructions when used for endovascular procedures.\n\n***UPDATE JUNE 2023***\n\nOn June 13, 2023, the firm sent an updated letter to customers to reflect an updated Risk to Health due to new complaint data. ALL LOTS of product, including lots manufactured after May 2020, are affected.", "product_quantity": "105,968 units", "distribution_pattern": "Foreign:\nAustralia\nAustria\nBahrain\nBelgium\nBosnia-Herzegovina\nBrazil\nBulgaria\nCanada\nChile\nColombia\nCosta Rica\nCyprus\nCzech Republic\nDenmark\nEcuador\nEgypt\nEl Salvador\nEstonia\nFinland\nFrance\nGermany\nGreat Britain\nGreece\nHong Kong\nHungary\nIceland\nIreland, Republic of\nIsrael\nItaly\nJapan\nJordan\nKuwait\nLatvia\nLebanon\nLithuania\nMacedonia\nMalaysia\nMalta\nMexico\nNetherlands\nNew Zealand\nNorway\nPanama\nParaguay\nPeru\nPhilippines\nPoland\nPortugal\nQatar\nReunion\nRussia\nSan Marino\nSaudi Arabia\nSingapore\nSlovak Republic\nSlovenia\nSouth African Republic\nSouth Korea\nSpain\nSweden\nSwitzerland\nTaiwan,\nThailand\nTrinidad and Tobago\nTurkey\nUnited Arab Emirates\nUruguay\nVietnam", "openfda": { "k_number": [ "K021901", "K000001", "K041269", "K033053", "K961507", "K032744", "K963241", "K934116", "K082284", "K001257", "K992510", "K024178", "K891411", "K083625", "K982184", "K033990", "K220424", "K945494", "K230269", "K050832", "K030947", "K031641", "K062511", "K201342", "K030567", "K181200", "K980163", "K023811", "K012544", "K050814", "K071604", "K141584", "K990221", "K021563", "K140382", "K003100", "K202204", "K121048", "K964121", "K013648", "K152842", "K031041", "K140472", "K212403", "K961296" ], "registration_number": [ "3011175548", "3008146331", "3005099803", "9681260", "3002807314", "3015225571", "3004837686", "1721504", "3006950086", "3012536737", "3015309643", "3010273872", "1724474", "1123137", "1820334", "3000247987", "1721676", "2124215", "3013337852", "3011458193", "3033589330", "1000121056", "3013440400", "3040096051", "3010173425", "3009582362", "3010665433", "3009906660" ], "fei_number": [ "1000123180", "3011175548", "3008146331", "3005099803", "3003094851", "3002807314", "3015225571", "3004837686", "1721504", "3006950086", "3012536737", "3015309643", "3010273872", "1820334", "3000247987", "1721676", "2124215", "3002807036", "3002806565", "3013337852", "3011458193", "3033589330", "1000121056", "3013440400", "3040096051", "3009582362", "3010665433", "3009906660" ], "device_name": "Prosthesis, Tracheal, Expandable", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.3720", "device_class": "2" } } ] }